ISRCTN73554751CompletedNot Applicable
A feasibility study for a randomised controlled trial to measure the impact of frenotomy in breastfed infants with tongue tie
Southmead Hospital (UK)0 sites100 target enrollmentStarted: October 20, 2011Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Term born infants with a functionally significant tongue tie (Hazelbaker Assessment Tool for Lingual Frenulum Function [HATLFF] score between 6-12) with breast feeding difficulties (LATCH score <-8)
- •2. Male and female participants
- •3. Upper Age Limit is 14 days
Exclusion Criteria
- •1. Preterm infants
- •2. Infants with serious congenital anomalies
- •3. Infants who have lost >10% of their birth weight unless found to be well enough after checking by a neonatologist
- •4. Infants with a HATLFF score of <6, and those over 2 weeks old will be excluded from the study
- •5. Mothers who do not want their baby to have surgery
- •6. Babies that have not received vitamin K soon after birth, unless the mother agrees to an injection of vitamin K one hour before entering the trial
Investigators
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